Actively Recruiting
[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer
Led by Leiden University Medical Center · Updated on 2025-08-27
250
Participants Needed
10
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if a new type of scan, FAPI-PET/CT, can help find metastases of gastric cancer. We want to know how well this scan works for this purpose and whether it is less burdensome for patients compared to the methods we currently use to find metastases. The main questions it aims to answer are: * In how many patients can FAPI-PET/CT find metastases, which leads to a change in their treatment plan as decided by their medical team, such as avoiding unnecessary surgeries and changing from treatment meant to cure the disease to treatment focused on comfort (palliative treatment)? * In how many patients does FAPI-PET/CT change the diagnostic process as decided by their medical team, like more biopsies or imaging, or changing the type (extent) of surgery needed? Apart from the usual care gastric cancer patients receive, participants will: * Undergo one additional scan, which will take approximately 2 hours in total (excluding travel time) * Complete a number of questionnaires, which will take approximately 4 hours in total
CONDITIONS
Official Title
[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven adenocarcinoma of the stomach or the esophagogastric junction (Siewert type III), by gastroscopy
- Age greater than or equal to 18 years
- Surgically resectable, advanced tumor (cT3-4b, N0-3, M0), as determined on gastroscopy and a contrast-enhanced CT of thorax and abdomen
- Intention to perform a gastrectomy, based on a multidisciplinary team meeting and shared decision making
- Patients must have given written informed consent
- Patients who have recently participated in an interventional study with an investigational medicinal product may only participate if an interaction with study procedures is deemed unlikely by the study team
You will not qualify if you...
- Siewert type I-II esophagogastric junction tumor
- Unfit or unwilling to undergo study procedures
- Unfit or unwilling to undergo surgery
- Pregnancy at time of the [18F]AlF-FAPI-74 PET/CT scan
- Incapacitated subjects without decision-making capacity
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Illiterate patients unable to complete the resource use and quality of life questionnaires
- Inability to undergo PET/CT scans due to claustrophobia, weight limits, or inability to lie flat for approximately 30 minutes
AI-Screening
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Trial Site Locations
Total: 10 locations
1
ZGT
Almelo, Netherlands
Not Yet Recruiting
2
Amsterdam UMC
Amsterdam, Netherlands
Not Yet Recruiting
3
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, Netherlands
Not Yet Recruiting
4
Rijnstate
Arnhem, Netherlands
Not Yet Recruiting
5
Catharina Ziekenhuis
Eindhoven, Netherlands
Not Yet Recruiting
6
Zuyderland
Geleen, Netherlands
Not Yet Recruiting
7
UMC Groningen
Groningen, Netherlands
Not Yet Recruiting
8
Leids Universitair Medisch Centrum
Leiden, Netherlands
Actively Recruiting
9
Erasmus MC
Rotterdam, Netherlands
Not Yet Recruiting
10
UMC Utrecht
Utrecht, Netherlands
Not Yet Recruiting
Research Team
S
Sarah Spruijt, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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